KBI: US - Process Engineer III

Process Engineering is responsible for all Manufacturing process equipment and ensures the equipment and site infrastructure is in an active state to support cGMP operations.

As a Process Engineer, you will act as member of a cross-functional team to support implementation of new systems and improvements to existing manufacturing processes and equipment. You will apply sound scientific and engineering principles to successfully define upstream and downstream process equipment requirements, specifications and standards for facility fit, and assess equipment design and operation in a commercial cGMP production facility. This may include upstream activities such as cell culture and harvest, and/or downstream processes such as chromatography, purification, and filtration. You will be at the forefront of existing best practices and evaluating technologies.

What You Can Expect

• You will support equipment commissioning and qualification activities related to new or modified processes.
• Collaborate with MS&T and Manufacturing teams to troubleshoot and resolve equipment and process-related issues in manufacturing systems.
• Communicate with other KBI sites for problem solving and consistency of processes through the organization.
• Contribute to developing a culture of continuous improvements on processes and tools in close collaboration with other.
• You will perform facility fit activities for various production scenarios.
  
  
  

What We Expect

• You should be able to apply engineering principles in-order to problem-solve and drive projects to successful completion within defined timelines.
• The ability to manage multiple concurrent projects and resources.
• You should have the ability to work independently and have excellent communication skills.
  
  
  

Minimum Requirements:

• Process Engineer III: Bachelor of Science degree in mechanical or chemical engineering with minimum of 6 years industry experience or Master’s with 2-4 years industry experience.
• Experience in upstream and/or downstream operations and equipment in biologics
• Experience with GMP compliance requirements and working knowledge of clinical and commercial production, safety standards, and industry best practices
• Proven experience in the design, specification, and FATs for process equipment.
• Ability to work in a fast-paced, dynamic environment and manage multiple priorities.
  
  
  

Preferred:

• Continuous Improvement: Familiarity with Lean, Six Sigma, or other continuous improvement tools is advantageous.
• Extensive experience in process engineering, with a strong focus on drug substance biologics projects. Experience with a solid background may also be considered.
• Experience working with clean utilities.
• Project management techniques and tools
  
  
  

Required Knowledge / Skills / Experience:

• Ability to concisely write reports and to effectively communicate information to executive management, managers, technicians, government agencies and customers.
• Ability to apply engineering principles and problem-solving skills to everyday challenges.
• Strong math and analytical skills required. Ability to perform heat load calculations and size utility systems. Ability to apply mathematical operations to such tasks as frequency distribution, variance analysis, and determination of reliability and validity.
• Computer Applications: Microsoft Office (Word, Excel, PowerPoint, and Project), AutoCAD
• Tools: Standard hand tools, power tools, hand-held instrumentation
  
  
  

Physical Demands:

• Execution of assigned tasks will require the ability to access hard to reach areas of the facility to include confined spaces, cramped or low ceilings, interstitials, and mechanical rooms.
• Ability to climb stairs and ladders.
• Candidates must be able to balance on one foot for gowning into cleanrooms/clean spaces.
  
  
  

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.